Siemens Medical Solutions USA, Inc Recall 89915
Description: syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Siemens Medical Solutions USA, Inc Recall 89915 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0995-2022 |
| Event ID | 89915 |
| Event Description | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom. |
| Quantity | 1 (US) |
| Recall Reason | Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step. |
| Device Classification | 20220504 |
| Device Code Info | Partial UDI: 04056869051314, Serial Number 112261 |
| Center Classification Date | 20220422 |
| Recall Initiation Date | 20220307 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | |
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